• Provide strategic and operational leadership for clinical research activities across the organization • Monitor operational performance across the research program, including study activation timelines, enrollment performance, key performance indicator (KPI) monitoring, and operational efficiency • Support alliance management activities with key industry partners to maintain strong sponsor relationships and promote continued research collaboration and portfolio growth. • Ensure alignment on study execution, operational expectations, and performance metrics across sponsor and CRO partnerships. • Direct vendor strategy and oversight for clinical research operations, including selection, contracting support, performance monitoring, and relationship management for vendors supporting clinical trial execution. • Lead the preparation, negotiation, and management of clinical trial agreements, confidentiality agreements, and related research contracts in collaboration with sponsors and internal stakeholders. • Provide hands-on grant management, including preparing budgets, submitting applications, tracking award progress, and preparing required progress reports. • Support research billing compliance processes, including research billing determinations and coordination with compliance and revenue cycle teams. • Cultivate strong partnerships with physician investigators to advance clinical research participation, supporting study feasibility, portfolio growth, and enrollment performance.

Clinical Trial Associate (start-up support) ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development What you will be doing - The SSU Clinical Study Administrator is responsible for ensuring vendor spreadsheets are completed correctly and processed (submitted to vendor or global team) according to study team guidelines. - SSU CSA will attend weekly Study Team meetings to report on vendor Spreadsheets. - SSU CSA will participate in vendor management activities Your profile - Bachelor's degree or relevant clinical trial experience - Industry expereince in clinical trial support required (CRO/Pharma) with a focus on vendor support during Start-Up - Experience with vendor management, strong verbal & written communication skills, - and strong organizational skills - Previous administrative experience - Proven organizational and administrative skills - Computer proficiency - Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities - Team oriented and flexible; ability to respond quickly to shifting demands and - opportunities - Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to study Start-up, together with an understanding of the ICH/GCP guidelines - Ability to develop advanced computer skills to increase efficiency in day-to-day tasks - Good interpersonal skills and ability to work in an international team environment - Willingness and ability to train others on study administration procedures - Integrity and high ethical standards What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: - Various annual leave entitlements - A range of health insurance offerings to suit you and your family’s needs. - Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. - Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being. - Life assurance - Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

• Support multiple projects in clinical research and clinical trials. • Manage tasks related to clinical trials: recruitment, data management, and regulatory management. • Assist with audits and quality assurance reviews; prepare and attend site visits. • Assist with the preparation of IRB applications and document maintenance. • Collect and process biological specimens for studies when needed (Ex: blood, saliva, urine, placenta, breastmilk). • Evaluate and track the eligibility of all patients seen in the clinic. • Recruit subjects to participate in the assigned study using approved methodologies. • Conduct the enrollment of study participants, explain research procedures, and obtain informed consent. • Schedule appointments of study participants; conduct reminder phone calls and/or send mail-outs. • Perform biospecimen collection for study purposes, including but not limited to: blood (phlebotomy), saliva (cheek swabs), urine collection, breastmilk collection, and placental tissue. • Perform office-related duties such as managing communications, updating policy manuals, maintaining records, etc. • Review and abstract medical records for inclusion/exclusion criteria. • Access patient demographic and clinical information from clinical systems. • Supervise and train student research assistants in EMR data abstraction and data entry. • Review data for quality and completeness.

• Support the execution of cardiovascular trials by translating scientific and clinical strategy into high-quality study delivery across global, complex, late-stage clinical trials. • Provide hands-on oversight of protocol execution, medical data review, endpoint quality, and cross-functional issue resolution to enable timely, decision-ready data. • Serve as a clinical and scientific subject-matter expert for cardiovascular trials, with deep understanding of cardiovascular disease, endpoint strategy, protocol execution, and data integrity. • Contribute to medical monitoring activities and support ongoing review of subject-level and aggregate clinical data to identify safety signals, endpoint trends, protocol deviations, and emerging operational or scientific risks. • Present information internally and externally, anticipating and actively managing issues across a broad spectrum of cross-functional stakeholders, governance bodies, and external partners. • Provide guidance and oversight in the identification and management of collaborators, consultants, adjudication vendors, and/or Clinical Research Organizations (CROs) to support successful trial delivery. • Work cross-functionally to translate clinical strategy into study concept documents, protocols, endpoint definitions, charters, data review plans, and other key trial documents required for CV trial execution. • Ensure the scientific and operational integrity of protocols and clinical plans, including delivery of final protocol content and governance approvals for large, global, event-driven studies. • Provide clinical input into study startup, trial conduct, enrollment oversight, endpoint ascertainment, adjudication readiness, data review, and interpretation of results. • Review and analyze clinical trial data to ensure accuracy, completeness, consistency, and adherence to protocol, endpoint definitions, and regulatory requirements, with strong focus on MACE and other cardiovascular outcome measures where applicable. • Lead thorough data quality assessments in the context of a data monitoring and review plan to maintain high standards of endpoint reliability, safety oversight, and inspection readiness throughout the trial lifecycle.